Department of Internal Medicine, Herlev Gentofte University Hospital, Section of Respiratory Medicine, Copenhagen University Hospital, Herlev Gentofte, Hellerup, Denmark.
Department of Respiratory Medicine and Infectious Diseases, Copenhagen University Hospital, Bispebjerg Frederiksberg, Denmark.
Respir Res. 2024 Jun 6;25(1):236. doi: 10.1186/s12931-024-02860-9.
The effect of dual systemic antibiotic therapy against Pseudomonas aeruginosa in patients with pre-existing lung disease is unknown. To assess whether dual systemic antibiotics against P. aeruginosa in outpatients with COPD, non-cystic fibrosis (non-CF) bronchiectasis, or asthma can improve outcomes.
Multicenter, randomised, open-label trial conducted at seven respiratory outpatient clinics in Denmark. Outpatients with COPD, non-CF bronchiectasis, or asthma with a current P. aeruginosa-positive lower respiratory tract culture (clinical routine samples obtained based on symptoms of exacerbation not requiring hospitalisation), regardless of prior P. aeruginosa-status, no current need for hospitalisation, and at least two moderate or one hospitalisation-requiring exacerbation within the last year were eligible. Patients were assigned 1:1 to 14 days of dual systemic anti-pseudomonal antibiotics or no antibiotic treatment. Primary outcome was time to prednisolone or antibiotic-requiring exacerbation or death from day 20 to day 365.
The trial was stopped prematurely based in lack of recruitment during the COVID-19 pandemic, this decision was endorsed by the Data and Safety Monitoring Board. Forty-nine outpatients were included in the study. There was a reduction in risk of the primary outcome in the antibiotic group compared to the control group (HR 0.51 (95%CI 0.27-0.96), p = 0.037). The incidence of admissions with exacerbation within one year was 1.1 (95%CI 0.6-1.7) in the dual antibiotic group vs. 2.9 (95%CI 1.3-4.5) in the control group, p = 0.037.
Use of dual systemic antibiotics for 14 days against P. aeruginosa in outpatients with chronic lung diseases and no judged need for hospitalisation, improved clinical outcomes markedly. The main limitation was the premature closure of the trial.
ClinicalTrials.gov, NCT03262142, registration date 2017-08-25.
目前尚不清楚针对患有基础肺部疾病的患者，使用双重全身抗生素治疗铜绿假单胞菌的效果如何。本研究旨在评估对慢性阻塞性肺疾病（COPD）、非囊性纤维化（非 CF）支气管扩张症或哮喘门诊患者使用针对铜绿假单胞菌的双重全身抗生素是否可以改善结局。
这是一项在丹麦 7 家呼吸门诊进行的多中心、随机、开放标签试验。纳入符合条件的患者为 COPD、非 CF 支气管扩张症或哮喘门诊患者，其下呼吸道当前存在铜绿假单胞菌阳性培养（基于无需住院治疗的恶化症状采集的临床常规样本），无论其既往铜绿假单胞菌状态如何、当前无需住院治疗、且在过去 1 年内至少有 2 次中度恶化或 1 次需住院治疗的恶化。将患者按 1:1 随机分配接受 14 天的双重全身抗假单胞菌抗生素治疗或不接受抗生素治疗。主要结局为从第 20 天到第 365 天的泼尼松龙或抗生素治疗恶化或死亡的时间。
由于在 COVID-19 大流行期间招募不足，试验提前终止，数据和安全监测委员会批准了这一决定。本研究共纳入 49 例门诊患者。与对照组相比，抗生素组的主要结局风险降低（HR 0.51（95%CI 0.27-0.96），p=0.037）。在一年内，双重抗生素组因恶化而住院的发生率为 1.1%（95%CI 0.6-1.7），而对照组为 2.9%（95%CI 1.3-4.5），p=0.037。
对无住院治疗指征的慢性肺部疾病门诊患者使用针对铜绿假单胞菌的双重全身抗生素治疗 14 天，可显著改善临床结局。主要限制是试验提前关闭。
ClinicalTrials.gov，NCT03262142，注册日期 2017 年 8 月 25 日。
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